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SCOTTSDALE, AZ, UNITED STATES, October 31, 2024
Blue Goat Cyber, a leader in medical device cybersecurity and FDA regulatory compliance, is excited to announce the launch of its Monthly Medical Device Cybersecurity Webinar Series starting November 26, 2024. This series, designed for medical device manufacturers, regulatory affairs professionals, and cybersecurity experts, will deliver in-depth guidance on critical topics such as Threat Modeling, Software Bill of Materials (SBOMs), Cybersecurity Labeling, Risk Methodologies, and Penetration Testing, aimed at aligning with FDA and EU MDR regulations while enhancing patient safety.
Responding to the Growing Demand for Device Security
As medical devices become more interconnected, their cybersecurity risks intensify, posing potential threats to both patient safety and data integrity. Manufacturers must now integrate robust cybersecurity measures from the earliest stages of device design through the entire product lifecycle, a necessity underscored by FDA guidelines and the EU Medical Device Regulation (MDR) requirements.
Blue Goat Cyber’s webinar series seeks to empower attendees with the latest best practices, regulatory updates, and hands-on strategies to enhance device security. Christian Espinosa, Founder of Blue Goat Cyber and author of Medical Device Cybersecurity: An In-Depth Guide, emphasizes, “Cybersecurity risks in medical devices are an urgent issue. Our goal with this series is to equip medical device professionals with actionable insights into regulatory compliance and effective cybersecurity measures, ensuring the highest levels of patient safety and device reliability.”
Webinar Series Highlights and Key Topics
Each monthly session will focus on practical, regulatory-aligned strategies for building resilient, secure medical devices. Key topics include:
– Threat Modeling for Medical Devices: Identifying, prioritizing, and mitigating security threats throughout the device lifecycle.
Software Bill of Materials (SBOM): Best practices for creating, managing, and maintaining SBOMs to improve transparency and compliance.
– Cybersecurity Labeling and Regulatory Requirements: Guidance on communicating device security features and usage instructions.
– Advanced Risk Methodologies: Exploring risk management frameworks that align with FDA and MDR requirements.
– Penetration Testing and Vulnerability Assessment: Penetration testing techniques to identify and address vulnerabilities before they impact device safety.
The series draws on the comprehensive approach detailed in Medical Device Cybersecurity: An In-Depth Guide, written by Espinosa, which includes real-world scenarios, hands-on tips, and insights from FDA and IEC 62304 standards for secure software lifecycle processes.
Why Attend?
This webinar series is an ideal platform for those in the medical device industry to understand regulatory and technical cybersecurity requirements better. Each session will feature:
– Practical Knowledge and Expert Insights from Blue Goat Cyber’s experienced team.
– Case Studies and Real-World Scenarios will highlight effective security measures and common pitfalls.
– Regulatory-focused training to guide attendees through FDA premarket submissions, MDR requirements, and more.
– Q&A and Networking Opportunities to engage with industry professionals and build a community centered on cybersecurity best practices.
About Blue Goat Cyber
Blue Goat Cyber is a trusted partner for medical device manufacturers worldwide, offering end-to-end cybersecurity solutions to ensure device resilience, patient safety, and regulatory compliance. From initial risk assessment and threat modeling to ongoing postmarket surveillance and compliance support, Blue Goat Cyber is dedicated to securing healthcare technology and advancing patient safety through effective cybersecurity.
How to Register
Registration details for the first webinar, which will launch on November 26, 2024, will be announced soon. To receive updates, please visit Blue Goat Cyber’s website or contact [email protected].
